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Pharmaceutical particulars
Excipients
Lyophilisate: Disodium phosphate dihydrate, hydrolysed gelatin, sucrose
Solvent: Disodium phosphate dihydrate, potassium dihydrogen phosphate, water for injections
Major incompatibilities
Do not mix with any other vaccine or immunological product except the solvent supplied with the product or with the vaccine in the Nobivac range containing rabies antigen, strain Pasteur RIV (where this product and the combined use is authorised).
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale:
Lyophilisate: 2 years
Solvent: 5 years.
Shelf life after reconstitution according to directions: 30 minutes.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2 °C – 8 °C). Do not freeze. Protect from light.
Solvent: Can be stored below 25 °C if stored separately from the lyophilisate. Do not freeze.
Immediate packaging
Lyophilisate:
1 dose vial of glass type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Solvent:
1 dose vial of glass type I (Ph. Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes:
Cardboard or plastic boxes with 5 x 1 dose, 10 x 1 dose, 25 x 1 dose or 50 x 1 dose of lyophilisate and solvent. Not all pack-sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirement.